Company Overview: A leading global Clinical Research Organisation (CRO) with a global presence is seeking a highly skilled and motivated Regulatory Submissions Manager to join its dynamic team.
Responsibilities:
Regulatory Strategy:
- Develop and implement regulatory submission strategies for [products/therapeutic areas] in alignment with business goals and regulatory requirements.
Submission Planning and Coordination:
- Plan, coordinate, and manage the preparation of regulatory submissions documents.
- Ensure submissions are complete, accurate, and comply with relevant regulatory guidelines and standards.
Cross-functional Collaboration:
- Collaborate with cross-functional teams, including Regulatory Affairs, Clinical Development, Quality Assurance, and R&D, to gather necessary information for submissions.
- Provide guidance to project teams on regulatory submission requirements and timelines.
Regulatory Documentation Management:
- Maintain and organize a repository of regulatory documents, ensuring version control, accessibility, and compliance with documentation standards.
Quality Assurance and Compliance:
- Ensure that all regulatory submissions meet the highest quality standards and adhere to applicable regulatory requirements
Health Authority Interactions:
- Facilitate interactions with regulatory agencies, including preparing and coordinating responses to agency inquiries and requests for additional information.
Regulatory Intelligence:
- Stay abreast of evolving regulatory requirements, guidelines, and industry trends to provide strategic input on regulatory matters.
Requirements:
- Bachelor's Degree in Science or a related field preferred.
- More than five years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
If you are highly motivated and dedicated, please apply with your CV attached.
